The Biden administration’s decision to finalize its narrow coverage decision for Biogen’s Aduhelm as attention now turns to efforts to scale back a major hike to Medicare Part B premiums.
The Centers for Medicare and Medicaid Services announced late Thursday that it will finalize its proposal for Medicare to cover Aduhelm and related drugs but only for beneficiaries in qualifying clinical trials. Insurer groups lauded the decision and key clarifications.
“We appreciate that when these treatments receive an accelerated FDA approval, Medicare will cover for patients in [Food and Drug Administration] or [National Institutes of Health] approved trials,” according to a statement from insurance lobbying group AHIP.
The FDA granted accelerated approval to Biogen’s Aduhelm last year to treat mild cognitive impairment caused by Alzheimer’s disease by treating amyloid plaques in the brain.
But insurers and some providers have been wary about prescribing the drug. A survey of major insurers conducted by Bloomberg found that a majority questioned whether the drug was medically necessary and followed criticism by the FDA’s own advisers that Aduhelm wasn’t effective.
CMS’ final decision kept a requirement that Medicare only cover the class of drugs that treat amyloid plaques for beneficiaries in a qualifying trial. However, the agency created a new pathway that would provide broader coverage requirements for any drugs in the class that got traditional approval.
AHIP applauded CMS for covering the drug and “related services such as PET scans if required b the trial protocol.”
Other stakeholders said that now the coverage decision has been finalized it is time for CMS to take action on lowering Part B premiums.
CMS has yet to announce any final decision on Part B premiums, which it increased by 15% for 2022. A key reason was the $56,000 price tag for Aduhelm.
However, Department of Health and Human Services Secretary Xavier Becerra announced in January that the agency was rethinking the 15% hike after Biogen halved the price of Aduhelm in December.
Becerra told reporters on Tuesday before the coverage decision that he was waiting to see what “CMS gives back to us in terms of their assessment and then once we get that information we will see where we go.”
CMS told Fierce Healthcare on Friday that it has yet to decide on a redetermination for the premium.
But advocates are hoping the agency moves faster on scaling back the premium hike.
“Medicare beneficiaries struggling to pay their bills need relief from this year’s premium increase as soon as possible,” said Max Richtman, president and CEO of the National Committee to Preserve Social Security and Medicare.
Pharma and Alzheimer’s disease patient advocacy groups slammed the decision, however, noting that it will hamper access to the drug.
“CMS has further complicated matters by taking the unprecedented step of applying different standards for coverage of medicines depending on the FDA approval pathway taken, undermining the scientific assessment by experts at FDA,” said Nicole Longo, spokeswoman for the Pharmaceutical Research and Manufacturers of America, in a statement.